Naming New Drugs: It’s Serious Business, Particularly in NJ

Naming New Drugs: It’s Serious Business, Particularly in NJ

With two-thirds of the world’s largest pharmaceutical companies based in New Jersey, agencies spend a lot of time here working out what to name drugs

Creating a new drug may be science but coming up with a name for it is an art. And it’s one for which pharmaceutical companies pay outside agencies hundreds of thousands of dollars to assist in that project. With 14 of the world’s 20 largest pharmaceutical companies based in New Jersey, those outside agencies spend a lot of time in the Garden State.

Companies don’t just want a name that’s catchy to consumers, because truth be told, drug names don’t always roll easily off the tongue. Under federal regulations, a drug name cannot sound like that of another drug, and with so many pharmaceutical trademarks already taken, it’s hard to come up with something new — and memorable. The name also can’t make any medical claims or be overly promotional, like claiming it’s better, faster or more effective than its competitors.

The task is so cumbersome, the naming process starts even before the company submits the drug to the U.S. Food and Drug Administration for approval and can take from six months to a year-and-a-half to develop and cost from $75,000 to $250,000.

“There’s only 26 letters in the alphabet and quite a few drugs on the market, so you have to create names that will not be confused with each other, right? You don’t want somebody getting the wrong medication,” said Dominick Cirigliano, executive vice president at OptiBrand Rx, a branding firm that focuses on healthcare.

In 2016, for instance, the brand name of the antidepressant Brintellix was changed to Trintellix to avoid possible prescribing and dispensing errors related to the drug’s confusion with the blood thinner Brilinta — though that was one of the more recent. Some of the world’s most celebrated drugs had to be renamed after regulators squawked.

G.D. Searle originally chose the name Celebra (celecoxib) for its blockbuster arthritis drug, but a pharmacy professor complained it sounded too like Forest Laboratories’ antidepressant Celexa. The FDA agreed, and so Celebra was changed to Celebrex.

The brand name of Ortho-McNeil Neurologics’ Alzheimer’s drug Reminyl (galantamine HBr) was changed to Razadyne in 2005 because it sounded too like Sanofi-Aventis’ diabetes drug Amaryl (glimepiride).

And Takeda Pharmaceuticals North America Inc announced in March 2010 that Kapidex (dexlansoprazole) would be marketed as Dexilant (dexlansoprazole) — again after reports of dispensing errors, between Kapidex and Casodex (bicalutamide) and Kadian (morphine sulfate extended-release). The product is indicated for heartburn associated with symptomatic nonerosive gastroesophageal reflux disease, the healing of erosive esophagitis (EE), and the maintenance of healed EE.

Helping pharmacists to differentiate

Dominick Cirigliano

Cirigliano worked at a company that helped name Seroquel, an anti-schizophrenia drug that was already on the market when its manufacturer received a letter from regulators saying the name was too close to Serzone, another drug also in the same category. Not only that but given the way that pharmacists stack their shelves, whether they sorted their drugs by therapeutic area or by alphabetical order, those two products — both of which started with S-E-R — ended up next to each other. Cirigliano helped the company keep the drug’s name by changing its packaging and the look of the product, so pharmacists could more readily differentiate the two products. It put yellow highlighting behind the “quel” in Seroquel, and it capitalized all four letters.“We just wanted to make it look different,” he said. “You don’t confuse Nike and Reebok, right?”

The first thing a pharmaceutical company and its consultants do when considering what to name a drug is an analysis of the product they’re working on: the marketplace, what drugs are out there, what drugs are in the pipeline. Thus, they can identify “areas of opportunity,” such as how the drug works differently than others, what it brings to the table, how it benefits a patient, as well as advice for physicians on how to use it or what class of drug it is.

Cirigliano cited Adlyxine, a diabetic drug he helped name for Sanofi. The generic name was lixisenatide, so the brand name, Adlyxine, was meant to tell users that they could “add lixisenatide to insulin,” or “Add lixi in.”

Companies often use part of the drug’s generic name when it’s renamed, so physicians, whose first exposure to a drug is often through its generic name, will know it’s a drug with which they are already familiar. When Symbiomix, a drug company headquartered in Newark, launched its product to treat bacterial vaginosis, it took the generic name, secnidazole and turned it into Solosec, which is a once-daily — or “solo” — version of secnidazole, or the “sec” in Solosec. The “solo” prefix is meant to enforce the product’s key benefit, which is that you only need one administration daily.

Keeping the audience in mind

Names are also chosen based on their audience. A drug to be used primarily by physicians may play more on its chemical components while a drug bought directly by consumers may be easier to say and inspire a feeling or message. The name could be associated with a positive word such as “victory,” which was used in the diabetes drug, Victoza, or it could be linked to a word implying what it does, like using “levitate” in the drug, “Levitra,” which addresses erectile dysfunction, or “lune,” the root for moon, in the drug “Lunesta,” which is taken for insomnia, Cirigliano said.

Sometimes it’s not about a word but about a tone, as in the case of Gilenya, the first oral tablet to treat multiple sclerosis. The name has no real meaning or direct connection to anything about multiple sclerosis but brand consultants liked the sound — which patients say reminds them of the word “GIRL.” That’s helpful, given that more than half of the patients with MS are women, Cirigliano said.

“The girl part was not an intention at all, but as we’ve done research over the years on the name, many patients call out that they see ‘girl’ in the name,” he said.

Credit: Twenty20

Alphabet & letters

Letters are important as well. Drugs geared for women may start with an “S,” “M,” or “L,” because they’re easier to say, while the letters “H,” “J,” and “W” are not really used because they’re harder to say in other languages.“The name has to be distinctive from existing trademarks, essentially intellectual property that you have to be able to defend,” said Scott Piergrossi, vice president of creative and corporate communications at the Brand Institute, based in Florida. “And the name shouldn’t sound or look like anything that’s inappropriate or negative in every language, in the markets the drug will be marketed in.”

Doing a ‘disaster check’

A common example, from outside the drug world, was Chevy’s “Nova,” which meant “no-go” for a car in Spanish-speaking countries.

“We’ll test names in the different countries that the product will be marketed in to make sure the prefix doesn’t mean something derogatory or the name as a whole takes you somewhere inappropriate,” he said. “It doesn’t come up a lot, but it is a disaster check and it’s very important.”

When New Jersey-based Johnson & Johnson subsidiary Janssen named Tremfya, a drug that fights psoriasis, it used a word that evokes triumph or victory over an affliction. When Merck, also based here, named the Gardasil vaccine, which is for HPV prevention in young teenage girls, it used the word “guard” in the beginning of the word to connote protection or prevention. It named Belsomra, a prescription sleep-aid, by pairing the word “belle,” or beautiful, with the word “som,” to connote sleep.

“Notice how it doesn’t say, “Bellasleep” or “Sleepwella” or something like that. It’s suggestive,” Piergrossi said.

A perennial client favorite is Latisse, for eyelash growth, a product of New Jersey-based Allergan. The “La” is from “lash,” and the suffix, “tisse,” is for Matisse, the artist. It’s meant to suggest sculpted or pointy eyelashes, Piergrossi said.

Sending emotional cues

And then there’s Entresto, from Novartis, for congestive heart failure. The name sounds like, “entrust,” making people feel like they can entrust their health to this drug. It’s an emotional cue meant to aid in memorability and likability of the drug, Piergrossi said.

But companies must walk a tightrope, being creative while working within regulators’ safety rules. Drugs are the only product in the world that require government approval of the brand name in order to go to market, Piergrossi said, noting that the reason drug commercials seem so long is because companies are required to spend as much time telling a drug’s side effects as telling the drug’s benefits.

“When you give fair time to the safety side of the drug, then you’re essentially doubling the length of the commercial,” he said.

In fact, the development of a drug name is analogous to the development of the drug, itself, Piergrossi said.

Since the 1990s, the FDA has taken aim at medication errors. Piergrossi cites the case of the antacid or proton pump inhibitor, Losec, also known as omeprazole, which was released in 1989, around the same time there was another product on the market called Lasix, or furosemide, which treated fluid retention in people with congestive heart failure, liver disease, and kidney disorder. After reports of people being prescribed Lasix and receiving Losec, and vice versa — and that someone had died from the confusion — the FDA requested that the antacid, Losec, change its name. It’s now called Prilosec, one of the most popular antacids on the market.

“That’s a post-marketing name change request, and that doesn’t happen a lot,” Piergrossi said.

Evaluating name’s chances with FDA

Coming up with a name that is both novel and yet will pass regulatory muster is no easy task. In fact, there are companies that run tests to evaluate whether a name will be approved or not by the FDA. SafeMark Regulatory Consulting, for instance, will evaluate about 30 potential names at a time for a client, rate them on a scale of low-, moderate-, or high- risk of being declined. It will then prioritize the names according to their ratings.

“A lot of clients, they like the names that are in the moderate risk category, because what traditionally happens is names that are somewhat risky, do very well from a commercial standpoint,” said Dyan Rowe Davis, president of SafeMark.

Credit: Wikimedia Commons

FDA logo

The FDA released an algorithm called POCA, which stands for Phonetic Orthographic Computer Analysis software, and companies can type their prospective name, compare it to another product out there on the market already, and obtain a score from zero to 100 percent on how similar the two names are, both in terms of how they sound and what they look like. In order to make this comparison, the pharmaceutical company or its consultants must locate names similar to the one it is proposing. This is done by searching through various databases and surveying practitioners, from doctors and nurses, to anyone working in a pharmacy.The FDA has threshold values on how close is too close. And those are what Rowe Davis’ company takes into account when it rates names on a risk scale: Anything with a POCA score of 55 percent to 69 percent is a moderate risk of being rejected by the FDA, and a POCA score of 70 percent or higher is a high risk of being rejected.

SafeMark then looks at the drug characteristics of that product versus the new product, and whether it has the same dosage form or the same indications.

Conducting ‘harm analysis’

“Is there any chance that once these products coexist, a patient could go to their medicine cabinet and find both? That’s the analysis, and the harm analysis that we have to do,” Rowe Davis said. “It just doesn’t end with the POCA score. That’s kinda where we start.”

One letter can be the difference between an approval and a rejection, Rowe Davis said. She had a situation where a client went to the FDA with a name to review, the regulator challenged the name, the client changed one letter, its POCA score was sufficiently lowered, and the name was approved.

“It happened to be just one single letter that they changed, and (the FDA) didn’t have an issue with it,” Rowe Davis said. “So we never forget that each letter has a role in the name.”
When asked if she remembered which letters were involved, she said she did.